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The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in combination with bortezomib and dexamethasone to placebo in combination with bortezomib and dexamethasone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy.

Detailed Description

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel group, phase 3 study to compare efficacy and safety of masitinib 9 mg/kg/day to placebo in the treatment of patients with relapsing multiple myeloma who received one previous therapy.

Patients will receive study treatment (masitinib/placebo) with the standard therapy (bortezomib and dexamethazone).

Criteria for eligibility

Healthy Volunteers: No

Maximum Age: N/A

Minimum Age: 18 Years

Gender: Both

Criteria: Inclusion Criteria:

1. Patient with confirmed multiple myeloma requiring systemic therapy. All three criteria must be met:

- Clonal bone marrow plasma cells > 10%

- Presence of serum and/or urinary monoclonal protein

- Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: